University of Arizona Cancer Center, Tucson, AZ 85724-5024, USA.
J Med Econ. 2012;15(4):712-23. doi: 10.3111/13696998.2012.675380. Epub 2012 Mar 27.
With increasing healthcare resource constraints, it has become important to understand the incremental cost-effectiveness of new medicines. Subcutaneous denosumab is superior to intravenous zoledronic acid (ZA) for the prevention of skeletal-related events (SREs) in patients with advanced solid tumors and bone metastases. This study sought to determine the lifetime cost-effectiveness of denosumab vs ZA in this setting, from a US managed-care perspective.
A lifetime Markov model was developed, with relative rate reductions in SREs for denosumab vs ZA derived from three pivotal Phase 3 trials involving patients with castration-resistant prostate cancer (CRPC), breast cancer, and non-small-cell lung cancer (NSCLC), and bone metastases. The real-world SRE rates in ZA-treated patients were derived from a large commercial database. SRE and treatment administration quality-adjusted life year (QALY) decrements were estimated with time-trade-off studies. SRE costs were estimated from a nationally representative commercial claims database. Drug, drug administration, and renal monitoring costs were included. Costs and QALYs were discounted at 3% annually. One-way and probabilistic sensitivity analyses were conducted.
Across tumor types, denosumab was associated with a reduced number of SREs, increased QALYs, and increased lifetime total costs vs ZA. The costs per QALY gained for denosumab vs ZA in CRPC, breast cancer, and NSCLC were $49,405, $78,915, and $67,931, respectively, commonly considered good value in the US. Costs per SRE avoided were $8567, $13,557, and $10,513, respectively. Results were sensitive to drug costs and SRE rates.
Differences in pain severity and analgesic use favoring denosumab over ZA were not captured. Mortality was extrapolated from fitted generalized gamma function beyond the trial duration.
Denosumab is a cost-effective treatment option for the prevention of SREs in patients with advanced solid tumors and bone metastases compared to ZA. The overall value of denosumab is based on superior efficacy, favorable safety, and more efficient administration.
随着医疗保健资源的日益紧张，了解新药的增量成本效益变得尤为重要。与静脉唑来膦酸（ZA）相比，皮下注射地舒单抗在预防晚期实体瘤和骨转移患者的骨骼相关事件（SREs）方面更具优势。本研究旨在从美国管理式医疗的角度出发，确定在此背景下地舒单抗相对于 ZA 的终生成本效益。
本研究建立了一个终生马尔可夫模型，其中地舒单抗相对于 ZA 的 SRE 相对风险降低率来自涉及去势抵抗性前列腺癌（CRPC）、乳腺癌和非小细胞肺癌（NSCLC）以及骨转移患者的三项关键性 III 期试验。ZA 治疗患者的真实 SRE 发生率来自一个大型商业数据库。通过时间权衡研究来估算 SRE 和治疗管理质量调整生命年（QALY）的降低。从一个全国代表性的商业索赔数据库估算 SRE 成本。纳入药物、药物管理和肾脏监测成本。成本和 QALY 每年贴现 3%。进行了单因素和概率敏感性分析。
在所有肿瘤类型中，与 ZA 相比，地舒单抗可减少 SRE 发生数、增加 QALY，并增加终生总费用。在地舒单抗相对于 ZA 在 CRPC、乳腺癌和 NSCLC 中的成本效益比分别为 49405 美元、78915 美元和 67931 美元，在美国通常被认为是有价值的。每避免一次 SRE 的成本分别为 8567 美元、13557 美元和 10513 美元。结果对药物成本和 SRE 发生率敏感。
未捕捉到地舒单抗优于 ZA 的疼痛严重程度和镇痛药使用差异。死亡率是根据试验持续时间以外的拟合广义伽马函数外推得出的。
与 ZA 相比，地舒单抗是预防晚期实体瘤和骨转移患者 SRE 的一种具有成本效益的治疗选择。地舒单抗的总体价值基于其优越的疗效、良好的安全性和更高效的管理。
